Acoustic shock wave therapeutic methods to prevent or treat opioid addiction

ABSTRACT

The method of treating a patient addicted to pain medication or opioids has the step administering acoustic shock waves or pressure pulses to the patient. A second embodiment includes a treatment to reduce a patient&#39;s pain caused by a medical condition and/or medical procedure to reduce or eliminate the taking of addictive pain medication. The treatment has the step of administering acoustic shock waves or pressure pulses directed to an area near a source of the pain or to one or more reflexology zones or to one or more reflexology zones and to an area near the source of the pain or both to treat the medical condition or prior to the medical procedure or during the medical procedure or after the medical procedure or any combination thereof.

RELATED APPLICATIONS

The present invention is a division of U.S. Ser. No. 16/353,278 filed onMar. 14, 2019 which is a continuation in part of co-pending U.S.application Ser. No. 16/009,807 filed Jun. 15, 2018 entitled, “ImprovedAcoustic Shock Wave Therapeutic Methods” which is a continuation in partof co-pending applications U.S. Ser. No. 15/984,505 entitled “ImprovedAcoustic Shock Wave Therapeutic Methods” filed on May 21, 2018 and U.S.Ser. No. 15/131,303 entitled “Treatments For Blood Sugar Levels AndMuscle Tissue Optimization Using Extracorporeal Acoustic Shock Waves”filed on Apr. 18, 2016.

TECHNICAL FIELD

The present invention relates to an improved pre-treatment method ofutilizing acoustic shock waves or pressure pulses to reduce pain after amedical procedure and thereby reduce the need for prescribing addictivedosages of pain medications and a post treatment method to overcomeopioid addictions.

BACKGROUND OF THE INVENTION

In U.S. Pat. No. 7,470,240 B2, entitled “Pressure Pulse/Shock WaveTherapy Methods And An Apparatus For Conducting The TherapeuticMethods”, is disclosed a novel use of unfocused shock waves to stimulatea cellular substance. From this patent a family of treatment patentsevolved. The list includes U.S. Pat. Nos. 7,841,995; 7,883,482;7,905,845 all divisional applications; and U.S. Pat. No. 7,507,213entitled “Pressure Pulse/Shock Wave Therapy Methods For Organs”; U.S.Pat. No. 7,544,171 B2 entitled “Methods for Promoting Nerve Regenerationand Neuronal Growth and Elongation”; U.S. Pat. No. 7,988,648 B2 entitled“Pancreas Regeneration Treatment For Diabetics Using ExtracorporealAcoustic shock waves or pressure pulses”; all teaching a new useful wayto deliver acoustic shock waves or pressure pulses to achieve a healingresponse. Each of these patents are incorporated herein by reference intheir entirety. In addition, patents U.S. Pat. Nos. 8,257,282 and8,535,249 for the device to perform these methods by delivering lowenergy unfocused acoustic shock waves or pressure pulses to the cellulartissue being treated.

During this inventive research, the inventors disclosed the use ofacoustic shock waves or pressure pulses could be beneficial as a diseasepreventative therapy of at risk patients to such ailments as heartdisease and other conditions.

While this large volume of research has been rewarded by the granting ofnumerous patents, much new work has been evolving as the understandingof the technology is being applied. It is in this latest work that some,heretofore, unknown improvements and refinements have been discoveredthat were hidden from and unappreciated by scientists in this field. Inparticular, the use of acoustic shock waves or pressure pulses toregulate and in some cases stimulate glandular hormonal secretions ormodulate glandular hormonal secretions.

In recently filed co-pending U.S. patent application Ser. No. 15/984,505filed May 21, 2018 entitled “Improved Acoustic Shock Wave TherapeuticMethods” which is also being incorporated herein by reference in itsentirety discloses a method of modulating glandular secretions byadministering acoustic shock waves or pressure pulses to a gland,includes the steps of activating acoustic shock waves or pressure pulsesof an acoustic shock wave or pressure pulse generator to emit acousticshock waves or pressure pulses and subjecting the gland to acousticshock waves or pressure pulses stimulating the gland to have a modulatedresponse. The modulated response is one of an adjustment in hormonalrelease which increases low level output, decreases high level output orstabilizes erratic output.

This evolved into a method of modulating glandular secretions byadministering acoustic shock waves or pressure pulses to one or morereflexology zones or to one or more reflexology zones and to an areanear the source of the pain or region has been discovered. In onepreferred embodiment, a treatment method achieves one or more of a)modulating blood sugar levels, b) stimulating insulin production levelsor c) normalizing A1C levels by using the step of administering acousticshock waves or pressure pulses to one or more reflexology zones or toone or more reflexology zones and to an area near the source of the painor region. This treatment method, U.S. application Ser. No. 16/009,807filed on Jun. 15, 2018 entitled “Improved Acoustic Shock WaveTherapeutic Methods” is also incorporated herein by reference in itsentirety.

These most recent inventions have recently and quite unexpectedlydiscovered an improved treatment therapy that achieves all theobjectives of the earlier work in a newly discovered and remarkablyefficient way which directs acoustic shock waves or pressure pulses toreflexology regions to achieve a desired response.

The present invention has built upon this large volume of work with adiscovery that a pre-treatment of acoustic shock wave therapy prior toany medical procedure or optionally during such a procedure will reducethe patient's post treatment requirement for addictive pain medicationssuch as “opioids” and other addictive pain medications. Further, theability of acoustic shock waves or pressure pulses to reduce pain allowsthis shock wave therapy to be used to overcome addictions in patientsalready addicted as is described below.

By the turn of the 19th century, it was agreed that the stimulation ofsympathetic nerves could cause different effects on body tissues,depending on the conditions of stimulation (such as the presence orabsence of some toxin). Over the first half of the 20th century, twomain proposals were made to explain this phenomenon: There were (atleast) two different types of neurotransmitters released fromsympathetic nerve terminals, or There were (at least) two differenttypes of detector mechanisms for a single neurotransmitter.

The first hypothesis was championed by Walter Bradford Cannon and ArturoRosenblueth, who interpreted many experiments to then propose that therewere two neurotransmitter substances, which they called sympathin E (for‘excitation’) and sympathin I (for ‘inhibition’). The second hypothesisfound support from 1906 to 1913, when Henry Hallett Dale explored theeffects of adrenaline (which he called adrenine at the time), injectedinto animals, on blood pressure. Usually, adrenaline would increase theblood pressure of these animals Although, if the animal had been exposedto ergotoxine, the blood pressure decreased. He proposed that theergotoxine caused “selective paralysis of motor myoneural junctions”(i.e. those tending to increase the blood pressure) hence revealing thatunder normal conditions that there was a “mixed response”, including amechanism that would relax smooth muscle and cause a fall in bloodpressure. This “mixed response”, with the same compound causing eithercontraction or relaxation, was conceived of as the response of differenttypes of junctions to the same compound.

This line of experiments was developed by several groups, including DTMarsh and colleagues, who in February 1948 showed that a series ofcompounds structurally related to adrenaline could also show eithercontracting or relaxing effects, depending on whether or not othertoxins were present. This again supported the argument that the muscleshad two different mechanisms by which they could respond to the samecompound. In June of that year, Raymond Ahlquist, Professor ofPharmacology at Medical College of Georgia, published a paper concerningadrenergic nervous transmission. In it, he explicitly named thedifferent responses as due to what he called α receptors and βreceptors, and that the only sympathetic transmitter was adrenaline.While the latter conclusion was subsequently shown to be incorrect (itis now known to be noradrenaline), his receptor nomenclature and conceptof two different types of receptor mechanisms for a singleneurotransmitter, remains. In 1954, he was able to incorporate hisfindings in a textbook, Drill's Pharmacology in Medicine, and therebypromulgate the role played by α and β receptor sites in theadrenaline/noradrenaline cellular mechanism. These concepts wouldrevolutionize advances in pharmacotherapeutic research, allowing theselective design of specific molecules to target medical ailments ratherthan rely upon traditional research into the efficacy of pre-existingherbal medicines.

The present invention has been demonstrated to be able to modulate thesereceptors in a unique way in the absence of pharmaceutical drugs such asinhibitors.

SUMMARY OF THE INVENTION

The present invention immediately shuts down the inflammatory responseat the treatment site. This has been linked to modulation of varioussignaling molecules, including TLR3, NO, ATP, microvesicles andexosomes. Results are typically immediate and sustained relief ofchronic pain. The present invention sustainingly improves blood flow.This has been linked to the release of vascular endothelial growthfactor (VEGF) and other key growth factors and cytokines, as well as aboost in ATP, leading to neo angio/vasculogenesis at the treatment site,typically resulting in accelerated and sustaining regenerative effect.The shock waves and pressure pulses of the present invention technologyis scientifically validated to recruit and activate endogenous stemcells and elicit biofeedback by which “origins of pain” can be preciselyidentified, serving an invaluable role in treatment effectiveness andefficiency.

A treatment method to reduce a patient's pain caused by a medicalcondition and/or medical procedure to reduce or eliminate the taking ofaddictive pain medication is disclosed. The treatment has the step ofadministering acoustic shock waves or pressure pulses directed to one ormore reflexology zones or to one or more reflexology zones and to anarea near the source of the pain to treat the medical condition or priorto the medical procedure or during the medical procedure or after themedical procedure or any combination thereof. The treatment further hasthe steps of activating acoustic shock waves or pressure pulses of anacoustic shock wave or pressure pulse generator to emit acoustic shockwaves or pressure pulses and subjecting the one or more reflexologyzones or the one or more reflexology zones and an area near the sourceof the pain to acoustic shock waves or pressure pulses stimulating theone or more reflexology zones or the one or more reflexology zones andan area near the source of the pain to have a modulated response whereinthe modulated response is one or more of reducing patient anxiety bystimulating or modulating alpha and/or Beta adrenergic receptors tocontrol and reduce high stress and anxiety or suppressing pain oractivating an anesthetic effect over a period of time. Additionally, thetreatment further has the step of recruiting, activating anddifferentiating stem cells by directly targeting the pathologic tissueor by targeting the reflexology zones or doing both. Further,additionally, the treatment further has the step of modulatinginflammation locally by a direct targeting, or by modulating systemicinflammation by treating any or all of the reflexology zones, or bydoing both. The emitted acoustic shock waves or pressure pulses can befocused or unfocused acoustic shock waves or pressure pulses.

The reflexology zones are located in a region of a foot or hand or earof the patient. The shock wave or pressure pulse generator isacoustically coupled to the patient's skin using a coupling gel orliquid. The treatment method wherein the treatment reduces or eliminatessystemic or local inflammation. The treatment method wherein thetreatment initiates, activates or recruits stem cells. The treatmentmethod wherein the treatment reduces or eliminates systemic or localinflammation and initiates, activates or recruits stem cells.

Stimulating the one or more reflexology zones or the one or morereflexology zones and the area near a source of the medical condition orpain causes a stimulation or modulation of adrenergic receptors a and pand one or more of a release of nitric oxide, secretion of digestiveenzymes, hormones and other fluids and can cause a release of growthfactors including, but not limited to vascular endothelial growth factor(VEGF), can also cause new blood vessels to be created increasingvascularization. Stimulating the one or more reflexology zones or theone or more reflexology zones and the area near a source of the medicalcondition or pain also modulates and/or stimulates the adrenergic alphaand beta receptors to reduce and control a patient's stress and anxietyto calm patients reducing or eliminating pharmacologic compositions suchas serotonin uptake inhibitors and to facilitate treating pain drugaddicted patients by reducing withdrawal symptoms. The treatment methodcan be repeated one or more times prior to or during the medicalprocedure or after the medical procedure. The emitted acoustic shockwaves or pressure pulses can be low energy soft waves wherein the lowenergy soft waves have an energy density in the range of 0.01 mJ/mm² to1.0 mJ/mm², preferably in the range of 0.04 mJ/mm² to 0.3 mJ/mm². Eachsubjected reflexology zone receives between 100 and 100,000 acousticshock waves or pressure pulses per therapy session. The emitted acousticshock waves or pressure pulses are spherical, radial, convergent,divergent, planar, near planar, focused or unfocused from a source withor without a lens that is one of electrohydraulic, electromagnetic,piezoelectric, ballistic or water jets configured to produce an acousticshock wave and wherein the acoustic shock waves or pressure pulses areadministered invasively or noninvasively. Ideally, number of repeatedtreatments occur on a schedule over a period of three or more weeks, andtreatments can be repeated over time as a pain prevention protocol overlonger durations of time between repeated treatments.

An important embodiment has a method of treating a patient addicted topain medication. This method has the step of administering acousticshock waves or pressure pulses to the patient exhibiting an addiction topain medications or opioids wherein the administering of acoustic shockwaves or pressure pulses occurs at a location of one or more reflexologyzones or to one or more reflexology zones and to an area near the sourceof the pain at an extremity of the hands or the feet or the ears. Themethod allows the patient with the addiction to have a reduction inchronic pain. The method further has the steps of activating acousticshock waves or pressure pulses of an acoustic shock wave or pressurepulse generator to emit acoustic shock waves or pressure pulses;subjecting the location to acoustic shock waves or pressure pulsesstimulating the one or more reflexology zones or the one or morereflexology zones and the area near a source of the medical condition orpain to have a modulated response wherein the modulated response is oneor more of reducing patient anxiety or suppressing pain or activating ananesthetic effect over a period of time; and wherein the emittedacoustic shock waves or pressure pulses are focused or unfocusedacoustic shock waves or pressure pulses. The administration of emittedshock waves is additionally directed to the one or more reflexologyzones or the one or more reflexology zones and the area near a source ofthe medical condition or pain to modulate a response to the pain tosuppress urges to take the addictive medication or opioids and tominimize withdrawal symptoms. The treatment further allows substitutingprescribed addictive medications or opioids with non or less additivemedications.

DEFINITIONS

“A1C level”: refers to the Hemoglobin Ale (HbA1c) Test for Diabetes. Thehemoglobin Ale test measures average blood glucose over the past 2 to 3months. It's also called HbA1c, glycated hemoglobin test, andglycohemoglobin. People who have diabetes need this test regularly tosee if their levels are staying within range. It is used to determine ifthere is a need to adjust a person's diabetes medicines. The A1C test isalso used to diagnose diabetes.

“Adrenal Gland”: The adrenal glands (also known as suprarenal glands)are endocrine glands that produce a variety of hormones includingadrenaline and the steroids aldosterone and cortisol. They are foundabove the kidneys. Each gland has an outer cortex which produces steroidhormones and an inner medulla.

“Adrenaline”: Adrenaline, also known as adrenalin or epinephrine, is ahormone, neurotransmitter, and medication. Epinephrine is normallyproduced by both the adrenal glands and certain neurons. It plays animportant role in the fight-or-flight response by increasing blood flowto muscles, output of the heart, pupil dilation, and blood sugar.

“Adrenergic receptor”, the adrenergic receptors or adrenoceptors are aclass of G protein-coupled receptors that are targets of manycatecholamines like norepinephrine (noradrenaline) and epinephrine(adrenaline) produced by the body, but also many medications like betablockers, P2 agonists and a2 agonists, which are used to treat highblood pressure and asthma for example. Many cells have these receptors,and the binding of a catecholamine to the receptor will generallystimulate the sympathetic nervous system (SNS). SNS is responsible forthe fight-or-flight response, which is triggered for example by exerciseor fear causing situations. This response dilates pupils, increasesheart rate, mobilizes energy, and diverts blood flow from non-essentialorgans to skeletal muscle. These effects together tend to increasephysical performance momentarily.

“Aldosterone”: Aldosterone, the main mineralocorticoid hormone, is asteroid hormone produced by the zona glomerulosa of the adrenal cortexin the adrenal gland. It is essential for sodium conservation in thekidney, salivary glands, sweat glands and colon. It plays a central rolein the homeostatic regulation of blood pressure, plasma sodium (Na+),and potassium (K+) levels. It does so mainly by acting on themineralocorticoid receptors in the distal tubules and collecting ductsof the nephron. It influences the reabsorption of sodium and excretionof potassium (from and into the tubular fluids, respectively) of thekidney, thereby indirectly influencing water retention or loss, bloodpressure and blood volume. When dysregulated, aldosterone is pathogenicand contributes to the development and progression of cardiovascular andrenal disease.

“Blood sugar level”: The blood sugar level, blood sugar concentration,or blood glucose level is the amount of glucose present in the blood ofhumans and other animals Glucose is a simple sugar and approximately 4grams of glucose are present in the blood of a 70-kilogram (150 lb)human at all times. The body tightly regulates blood glucose levels as apart of metabolic homeostasis. Glucose is stored in skeletal muscle andliver cells in the form of glycogen; in fasted individuals, bloodglucose is maintained at a constant level at the expense of glycogenstores in the liver and skeletal muscle. Cellular glucose uptake isprimarily regulated by insulin, a hormone produced in the pancreas.Blood sugar levels outside the normal range may be an indicator of amedical condition. A persistently high level is referred to ashyperglycemia; low levels are referred to as hypoglycemia.

“Cortisol”: Cortisol is a steroid hormone, in the glucocorticoid classof hormones. When used as a medication, it is known as hydrocortisone.It is produced in humans by the zona fasciculata of the adrenal cortexwithin the adrenal gland. It is released in response to stress and lowblood-glucose concentration. It functions to increase blood sugarthrough gluconeogenesis, to suppress the immune system, and to aid inthe metabolism of fat, protein, and carbohydrates. It also decreasesbone formation.

A “curved emitter” is an emitter having a curved reflecting (orfocusing) or emitting surface and includes, but is not limited to,emitters having ellipsoidal, parabolic, quasi parabolic (generalparaboloid) or spherical reflector/reflecting or emitting elements.Curved emitters having a curved reflecting or focusing element generallyproduce waves having focused wave fronts, while curved emitters having acurved emitting surfaces generally produce wave having divergent wavefronts.

“Divergent waves” in the context of the present invention are all waveswhich are not focused and are not plane or nearly plane. Divergent wavesalso include waves which only seem to have a focus or source from whichthe waves are transmitted. The wave fronts of divergent waves havedivergent characteristics. Divergent waves can be created in manydifferent ways, for example: A focused wave will become divergent onceit has passed through the focal point. Spherical waves are also includedin this definition of divergent waves and have wave fronts withdivergent characteristics.

“Estrogen”: A female steroid hormone that is produced by the ovariesand, in lesser amounts, by the adrenal cortex, placenta, and maletestes. Estrogen helps control and guide sexual development, includingthe physical changes associated with puberty. It also influences thecourse of ovulation in the monthly menstrual cycle, lactation afterpregnancy, aspects of mood, and the aging process. Production ofestrogen changes naturally over the female lifespan, reaching adultlevels with the onset of puberty (menarche) and decreasing in middle ageuntil the onset of menopause. Estrogen deficiency can lead to lack ofmenstruation (amenorrhea), persistent difficulties associated withmenopause (such as mood swings and vaginal dryness), and osteoporosis inolder age. In cases of estrogen deficiency, natural and syntheticestrogen preparations may be prescribed. Estrogen is also a component ofmany oral contraceptives. An overabundance of estrogen in men causesdevelopment of female secondary sexual characteristics (feminization),such as enlargement of breast tissue.

“extracorporeal” means occurring or based outside the living body.

A “generalized paraboloid” according to the present invention is also athree-dimensional bowl. In two dimensions (in Cartesian coordinates, xand y) the formula yn=2px [with n being i−2, but being greater thanabout 1.2 and smaller than 2, or greater than 2 but smaller than about2.8]. In a generalized paraboloid, the characteristics of the wavefronts created by electrodes located within the generalized paraboloidmay be corrected by the selection of (p (−z,+z)), with z being a measurefor the burn down of an electrode, and n, so that phenomena including,but not limited to, burn down of the tip of an electrode (−z,+z) and/ordisturbances caused by diffraction at the aperture of the paraboloid arecompensated for.

“Hormone”: A hormone is any member of a class of signaling moleculesproduced by glands in multicellular organisms that are transported bythe circulatory system to target distant organs to regulate physiologyand behaviour. Hormones have diverse chemical structures, mainly of 3classes: eicosanoids, steroids, and amino acid/protein derivatives(amines, peptides, and proteins). The glands that secrete hormonescomprise the endocrine signaling system. The term hormone is sometimesextended to include chemicals produced by cells that affect the samecell (autocrine or intracrine signalling) or nearby cells (paracrinesignalling). Hormones are used to communicate between organs and tissuesfor physiological regulation and behavioral activities, such asdigestion, metabolism, respiration, tissue function, sensory perception,sleep, excretion, lactation, stress, growth and development, movement,reproduction, and mood. Hormones affect distant cells by binding tospecific receptor proteins in the target cell resulting in a change incell function. When a hormone binds to the receptor, it results in theactivation of a signal transduction pathway that typically activatesgene transcription resulting in increased expression of target proteins;non-genomic effects are more rapid, and can be synergistic with genomiceffects Amino acid-based hormones (amines and peptide or proteinhormones) are water-soluble and act on the surface of target cells viasecond messengers; steroid hormones, being lipid-soluble, move throughthe plasma membranes of target cells (both cytoplasmic and nuclear) toact within their nuclei. Hormone secretion may occur in many tissues.Endocrine glands are the cardinal example, but specialized cells invarious other organs also secrete hormones. Hormone secretion occurs inresponse to specific biochemical signals from a wide range of regulatorysystems. For instance, serum calcium concentration affects parathyroidhormone synthesis; blood sugar (serum glucose concentration) affectsinsulin synthesis; and because the outputs of the stomach and exocrinepancreas (the amounts of gastric juice and pancreatic juice) become theinput of the small intestine, the small intestine secretes hormones tostimulate or inhibit the stomach and pancreas based on how busy it is.Regulation of hormone synthesis of gonadal hormones, adrenocorticalhormones, and thyroid hormones is often dependent on complex sets ofdirect influence and feedback interactions involving thehypothalamic-pituitary-adrenal (HPA), -gonadal (HPG), and -thyroid (HPT)axes. Upon secretion, certain hormones, including protein hormones andcatecholamines, are water-soluble and are thus readily transportedthrough the circulatory system. Other hormones, including steroid andthyroid hormones, are lipid-soluble; to allow for their widespreaddistribution, these hormones must bond to carrier plasma glycoproteins(e.g., thyroxine-binding globulin (TBG)) to form ligand-proteincomplexes. Some hormones are completely active when released into thebloodstream (as is the case for insulin and growth hormones), whileothers are prohormones that must be activated in specific cells througha series of activation steps that are commonly highly regulated. Theendocrine system secretes hormones directly into the bloodstreamtypically into fenestrated capillaries, whereas the exocrine systemsecretes its hormones indirectly using ducts. Hormones with paracrinefunction diffuse through the interstitial spaces to nearby targettissue.

“Hypothalamus”: The hypothalamus is a portion of the brain that containsa number of small nuclei with a variety of functions. One of the mostimportant functions of the hypothalamus is to link the nervous system tothe endocrine system via the pituitary gland (hypophysis). Thehypothalamus is located below the thalamus and is part of the limbicsystem.

“Insulin”: is a hormone made by the pancreas that allows your body touse sugar, glucose, from carbohydrates in the food that is eaten forenergy or to store glucose for future use. Insulin helps keeps bloodsugar levels from getting too high (hyperglycemia) or too low(hypoglycemia).

“Melatonin”: Melatonin, also known as N-acetyl-5-methoxy tryptamine, isa hormone that is produced by the pineal gland in animals and regulatessleep and wakefulness. In animals, melatonin is involved in theentrainment (synchronization) of the circadian rhythms includingsleep-wake timing, blood pressure regulation, seasonal reproduction, andmany others. Many of its biological effects in animals are producedthrough activation of melatonin receptors, while others are due to itsrole as an antioxidant, with a particular role in the protection ofnuclear and mitochondrial DNA.

A “paraboloid” according to the present invention is a three-dimensionalreflecting bowl. In two dimensions (in Cartesian coordinates, x and y)the formula y2=2px, wherein p/2 is the distance of the focal point ofthe paraboloid from its apex, defines the paraboloid. Rotation of thetwo-dimensional figure defined by this formula around its longitudinalaxis generates a de facto paraboloid.

“Parathyroid”: Parathyroid glands are small endocrine glands in the neckof humans and other tetrapods that produce parathyroid hormone. Humansusually have four parathyroid glands, variably located on the back ofthe thyroid gland. Parathyroid hormone and calcitonin (one of thehormones made by the thyroid gland) have key roles in regulating theamount of calcium in the blood and within the bones.

“Parathyroid Hormone”: Parathyroid hormone (PTH) also calledparathormone or parathyrin, is a hormone secreted by the parathyroidglands that is important in bone remodeling, which is an ongoing processin which bone tissue is alternately resorbed and rebuilt over time. PTHis secreted in response to low blood serum calcium (Ca2+) levels. PTHindirectly stimulates osteoclast activity within bone marrow, in aneffort to release more ionic calcium (Ca2+) into the blood to elevateserum calcium (Ca2+) levels. The bones act as a (metaphorical) “bank ofcalcium” from which the body can make “withdrawals” as needed to keepthe amount of calcium in the blood at appropriate levels despite theever-present challenges of metabolism, stress, and nutritionalvariations. PTH is “a key that unlocks the bank vault” to remove thecalcium. In consequence, PTH is vital to health, and health problemsthat yield too little or too much PTH (such as hypoparathyroidism,hyperparathyroidism, or paraneoplastic syndromes) can wreak havoc in theform of bone disease, hypocalcaemia, and hypercalcaemia.

“Pineal body”: Pineal gland, also called conarium, epiphysis cerebri,pineal organ, or pineal body, endocrine gland. The pineal gland is asmall endocrine gland in the vertebrate brain. The pineal gland producesmelatonin, a serotonin-derived hormone which modulates sleep patterns inboth circadian and seasonal cycles. The shape of the gland resembles apine cone, hence its name The pineal gland is located in theepithalamus, near the center of the brain, between the two hemispheres,tucked in a groove where the two halves of the thalamus join.

“Pituitary gland”: In vertebrate anatomy, the pituitary gland, orhypophysis, is an endocrine gland about the size of a pea and weighing0.5 grams (0.018 oz) in humans. It is a protrusion off the bottom of thehypothalamus at the base of the brain. The hypophysis rests upon thehypophysial fossa of the sphenoid bone in the center of the middlecranial fossa and is surrounded by a small bony cavity (sella turcica)covered by a dural fold (diaphragma sellae). The anterior pituitary (oradenohypophysis) is a lobe of the gland that regulates severalphysiological processes (including stress, growth, reproduction, andlactation). The intermediate lobe synthesizes and secretesmelanocyte-stimulating hormone. The posterior pituitary (orneurohypophysis) is a lobe of the gland that is functionally connectedto the hypothalamus by the median eminence via a small tube called thepituitary stalk (also called the infundibular stalk or theinfundibulum). Hormones secreted from the pituitary gland help control:growth, blood pressure, management of energy, all functions of the sexorgans, thyroid glands and metabolism as well as some aspects ofpregnancy, childbirth, nursing, water/salt concentration at the kidneys,temperature regulation and pain relief.

“Plane waves” are sometimes also called flat or even waves. Their wavefronts have plane characteristics (also called even or parallelcharacteristics). The amplitude in a wave front is constant and the“curvature” is flat (that is why these waves are sometimes called flatwaves). Plane waves do not have a focus to which their fronts move(focused) or from which the fronts are emitted (divergent). “Nearlyplane waves” also do not have a focus to which their fronts move(focused) or from which the fronts are emitted (divergent). Theamplitude of their wave fronts (having “nearly plane” characteristics)is approximating the constancy of plain waves. “Nearly plane” waves canbe emitted by generators having pressure pulse/shock wave generatingelements with flat emitters or curved emitters. Curved emitters maycomprise a generalized paraboloid that allows waves having nearly planecharacteristics to be emitted.

A “pressure pulse” according to the present invention is an acousticpulse which includes several cycles of positive and negative pressure.The amplitude of the positive part of such a cycle should be above about0.1 MPa and its time duration is from below a microsecond to about asecond. Rise times of the positive part of the first pressure cycle maybe in the range of nano-seconds (ns) up to some milli-seconds (ms). Veryfast pressure pulses are called shock waves. Shock waves used in medicalapplications do have amplitudes above 0.1 MPa and rise times of theamplitude can be below 1000 ns, preferably at or below 100 ns. Theduration of a shock wave is typically below 1-3 micro-seconds (μs) forthe positive part of a cycle and typically above some micro-seconds forthe negative part of a cycle.

“Reflexology zone” as used herein means an area or pressure point on thefeet or hands that are access pathways to every organ, gland, muscle,etc. These pathways between pressure points and other parts of the bodyare thought to be connected via the nervous system and that aneurological relationship exists between the skin and the internalorgans, and that the whole nervous system adjusts to a stimulus.According to reflexology theory, application of pressure to feet, hands,or ears sends a calming message from the peripheral nerves in theseextremities to the central nervous system, which in turn signals thebody to adjust the tension level. This enhances overall relaxation,removes stress, brings internal organs and their systems into a state ofoptimum functioning, and increases blood supply which brings additionaloxygen and nutrients to cells and enhances waste removal. It positivelyaffects the circulatory, respiratory, endocrine, immune, andneuropeptide systems in the body.

“Reproductive glands” include ovaries and testes: A woman's 2 ovariesare located on each side of the uterus, just below the opening of thefallopian tubes (tubes that extend from the uterus to near the ovaries).The ovaries contain the egg cells needed for reproduction. They alsomake estrogen and progesterone. These affect many of the femalecharacteristics and reproductive functions. Estrogens also play animportant role in bone health and strength. The levels of estrogen andprogesterone are controlled by certain hormones made by the pituitarygland. The testes are oval-shaped organs that hang suspended in a pouchof skin (scrotum) outside the male body. The testes are the site ofsperm production. They also make testosterone and other hormones. Theseaffect many of the male characteristics and support sperm production.Testosterone also plays an important role in bone health and strength.

“Shock Wave”: As used herein is defined by Camilo Perez, Hong Chen, andThomas J. Matula; Center for Industrial and Medical Ultrasound, AppliedPhysics Laboratory, University of Washington, 1013 NE 40th Street,Seattle, Wash. 98105; Maria Karzova and Vera A. Khokhlovab; Departmentof Acoustics, Faculty of Physics, Moscow State University, Moscow119991, Russia; (Received 9 Oct. 2012; revised 16 Apr. 2013; accepted 1May 2013) in their publication, “Acoustic field characterization of theDuolith: Measurements and modeling of a clinical shock wave therapydevice”; incorporated by reference herein in its entirety.

“Testosterone”: Testosterone is the primary male sex hormone and ananabolic steroid. In male humans, testosterone plays a key role in thedevelopment of male reproductive tissues such as testes and prostate, aswell as promoting secondary sexual characteristics such as increasedmuscle and bone mass, and the growth of body hair. In addition,testosterone is involved in health and well-being, and the prevention ofosteoporosis. Insufficient levels of testosterone in men may lead toabnormalities including frailty and bone loss. Testosterone is a steroidfrom the androstane class containing a keto and hydroxyl groups at thethree and seventeen positions respectively. It is biosynthesized inseveral steps from cholesterol and is converted in the liver to inactivemetabolites. It exerts its action through binding to and activation ofthe androgen receptor. In humans and most other vertebrates,testosterone is secreted primarily by the testicles of males and, to alesser extent, the ovaries of females. On average, in adult males,levels of testosterone are about 7 to 8 times as great as in adultfemales. As the metabolism of testosterone in males is greater, thedaily production is about 20 times greater in men. Females are also moresensitive to the hormone.

“Thymus”: The thymus is a specialized primary lymphoid organ of theimmune system. Within the thymus, T cells mature. T cells are criticalto the adaptive immune system, where the body adapts specifically toforeign invaders. The thymus is composed of two identical lobes and islocated anatomically in the anterior superior mediastinum, in front ofthe heart and behind the sternum. Histologically, each lobe of thethymus can be divided into a central medulla and a peripheral cortexwhich is surrounded by an outer capsule. The cortex and medulla playdifferent roles in the development of T cells. Cells in the thymus canbe divided into thymic stromal cells and cells of hematopoietic origin(derived from bone marrow resident hematopoietic stem cells). DevelopingT cells are referred to as thymocytes and are of hematopoietic origin.Stromal cells include epithelial cells of the thymic cortex and medulla,and dendritic cells. The thymus provides an inductive environment fordevelopment of T cells from hematopoietic progenitor cells. In addition,thymic stromal cells allow for the selection of a functional andself-tolerant T cell repertoire. Therefore, one of the most importantroles of the thymus is the induction of central tolerance. The thymus islargest and most active during the neonatal and pre-adolescent periods.By the early teens, the thymus begins to atrophy and thymic stroma ismostly replaced by adipose (fat) tissue. Nevertheless, residual Tlymphopoiesis continues throughout adult life.

“Thyroid”: The thyroid gland, or simply the thyroid, is an endocrinegland in the neck, consisting of two lobes connected by an isthmus. Itis found at the front of the neck, below the Adam's apple. The thyroidgland secretes thyroid hormones, which primarily influence the metabolicrate and protein synthesis. The hormones also have many other effectsincluding those on development. The thyroid hormones triiodothyronine(T3) and thyroxine (T4) are created from iodine and tyrosine. Thethyroid also produces the hormone calcitonin, which plays a role incalcium homeostasis. Hormonal output from the thyroid is regulated bythyroid-stimulating hormone (TSH) secreted from the anterior pituitarygland, which itself is regulated by thyrotropin-releasing hormone (TRH)produced by the hypothalamus. The thyroid may be affected by severaldiseases. Hyperthyroidism occurs when the gland produces excessiveamounts of thyroid hormones, the most common cause being Graves'disease, an autoimmune disorder. In contrast, hypothyroidism is a stateof insufficient thyroid hormone production. Worldwide, the most commoncause is iodine deficiency. Thyroid hormones are important fordevelopment, and hypothyroidism secondary to iodine deficiency remainsthe leading cause of preventable intellectual disability. Iniodine-sufficient regions, the most common cause of hypothyroidism isHashimoto's thyroiditis, also an autoimmune disorder. In addition, thethyroid gland may also develop several types of nodules and cancer.

Waves/wave fronts described as being “focused” or “having focusingcharacteristics” means in the context of the present invention that therespective waves or wave fronts are traveling and increase theiramplitude in direction of the focal point. Per definition the energy ofthe wave will be at a maximum in the focal point or, if there is a focalshift in this point, the energy is at a maximum near the geometricalfocal point. Both the maximum energy and the maximal pressure amplitudemay be used to define the focal point.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by way of example and with reference tothe accompanying drawings in which:

FIG. 1 is a simplified depiction of a pressure pulse I shock wave(PP/SW) generator with focusing wave characteristics.

FIG. 2 is a simplified depiction of a pressure pulse I shock wave orpressure pulse generator with plane wave characteristics.

FIG. 3 is a simplified depiction of a pressure pulse I shock wave orpressure pulse generator with divergent wave characteristics.

FIG. 4a is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator having a focusing element in the form of anellipsoid. The waves generated are focused.

FIG. 4b is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator having a parabolic reflector element andgenerating waves that are disturbed plane.

FIG. 4c is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator having a quasi parabolic reflector element(generalized paraboloid) and generating waves that are nearly plane/havenearly plane characteristics.

FIG. 4d is a simplified graphic depiction of a generalized paraboloidwith better focusing characteristic than a paraboloid in which n=2. Theelectrode usage is shown. The generalized paraboloid, which is aninterpolation (optimization) between two optimized paraboloids for a newelectrode and for a used (burned down) electrode is also shown.

FIG. 5 is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator being connected to a control/power supply unit.

FIG. 6 is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator comprising a flat EMSE (electromagnetic shockwave emitter) coil system to generate nearly plane waves as well as anacoustic lens. Convergent wave fronts are leaving the housing via anexit window.

FIG. 7 is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator having a flat EMSE coil system to generatenearly plane waves. The generator has no reflecting or focusing element.As a result, the pressure pulse/shock waves are leaving the housing viathe exit window unfocused having nearly plane wave characteristics.

FIG. 8 is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator having a flat piezoceramic plate equipped witha single or numerous individual piezoceramic elements to generate planewaves without a reflecting or focusing element. As a result, thepressure pulse/shock waves are leaving the housing via the exit windowunfocused having nearly plane wave characteristics.

FIG. 9 is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator having a cylindrical EMSE system and atriangular shaped reflecting element to generate plane waves. As aresult, the pressure pulse/shock waves are leaving the housing via theexit window unfocused having nearly plane wave characteristics.

FIG. 10 shows an exemplary shock wave or pressure pulse generatordevice.

FIG. 11 shows the shock wave or pressure pulse generator device directedat one or more reflexology zones or to one or more reflexology zones andto an area near the source of the pain on a foot of a patient.

FIG. 12 shows the shock wave or pressure pulse generator device directedat one or more reflexology zones or to one or more reflexology zones andto an area near the source of the pain on a hand of a patient.

FIGS. 13-13C show schematic views showing general reflexology locationsof the foot and ankle area in the human body.

FIG. 14 shows a schematic view showing general reflexology locations ofthe hand in the human body.

DETAILED DESCRIPTION OF THE INVENTION

The present methodology uses an acoustic shock wave form directed tospecific reflexology zones to stimulate a modulated response. Thepresent invention described herein teaches a therapy to reduce thenumber of opioid addictions following surgery by reducing the need forpain medication post-surgery; and, aiding in the recovery from addictionof pain medications and opioids by elimination chronic pain in theaddict and minimizing the withdrawal symptoms in the addict.

The present inventors have treated hundreds of “addicts”, thoseindividuals suffering from prescription or opioid addiction,successfully including those patients who require pain medication and/oropiates daily to manage their pain such that a patient can participatein daily activities. A huge success rate is being achieved as they onlytreat those motivated patients who seek out treatment for their chronicinjuries and want to get off pain medication or opiates. Two million newaddicts are created annually following elective surgery in the USA.These people are target patients. Additionally, the present inventionhas had substantial success in treating long term addicts as well. Thisis especially true when an added incentive of a job treating otheraddicts is afforded with this technology upon the successful “kicking”of the addiction. This effort is part of a Kentucky project.

The inventors have also proven the ability to prevent long term chronicpain not only in their clinical experiences but in their published skinflap rat model. By treating the standardized skin flap of the mouse withshock waves they reduced the area of necrosis post-surgery by 75% andaccelerated complete healing by 50%. This must translate into painreduction and the need for pain meds. They treated the mouse a day priorto, or during surgery to reduce healing time and necrosis. This is thepreferred embodiment. Treat a patient during surgery to (1) preventadverse effects and prevent infection (2) reduce the recovery time and(3) reduce post-surgical pain. All 3 factor in long term pain medicationusage. The advantage of treating during surgery is that treating apatient in the acute injury phase is painful. During surgery one canincrease the energy level and the number of shocks to improve outcomesand reduce the amount of future pain medication, thus reducing thelikelihood of addiction.

Treating the reflexology zones in both hands and feet of the addict canminimize the anxiety and pain during the withdrawal period and generallyjust make the addict feel better. The inventors have seen this innumerous cases and this is included in this patent.

In the extracorporeal shock wave or pressure pulse method of treating apatient, the administered shock waves or pressure pulses are directed toa treatment location or target site on the anatomy. In this invention,the term target site refers to either a location near the source of themedical condition or pain or to a reflexology location for a specificorthopedic bone structure, nerve, gland and the tissue of the hand orfoot at the desired reflexology zone or region being in the path of theshock wave applicator. As used herein, “near” recognizes that theemitted shock waves or pressure pulses are transmitted through the skinand subcutaneous tissue directed toward the treatment location,preferably at or in close proximity to the treatment location or site.The patient is placed in a convenient orientation to permit the sourceof the emitted waves to most directly send the waves to the target siteto initiate shock wave stimulation of the target area. Assuming thetarget area is within a projected area of the wave transmission, asingle transmission dosage of wave energy may be used. The transmissiondosage can be from a few seconds to 20 minutes or more dependent on thecondition. Preferably the waves are generated from an unfocused orfocused source. The unfocused waves can be divergent or near planar andhaving a low-pressure amplitude and density in the range of 0.00001mJ/mm² to 1.0 mJ/mm² or less, most typically below 0.2 mJ/mm². Thefocused source can use a focused beam of waves or can optionally use adiffusing lens or have a far-sight focus to minimize if not eliminatehaving the localized focus point within the tissue. Preferably thefocused shock waves are used at a similarly effective low energytransmission or alternatively can be at higher energy but wherein thetissue target site is disposed pre-convergence inward of the geometricfocal point of the emitted wave transmission. Understanding the higherthe energy used, the more sensation of pain the patient may experience.

These shock wave energy transmissions are effective in stimulating acellular response and in some cases, such as unfocused low energy, andeven low energy focused emissions can be accomplished without creatingthe localized hemorrhaging caused by rupturing cavitation bubbles in thetissue of the target site. This effectively insures the patient does nothave to experience the sensation of pain so common in the higher energyfocused wave forms having a focal point at or within the targetedtreatment site. Higher energy acoustic shock waves or pressure pulsesincluding focused ways can be used if the patient is adequately sedatedsuch as during a surgical preparation or even during a surgicalprocedure.

Accordingly, unless for other reasons such as a trauma or immediatepost-operative shock wave therapy no localized or general anesthesia isrequired. Post-operative shock wave therapy typically will beadministered without such sedations at low energy.

If the target site is within the body, it may be such that the patientor the generating source must be reoriented relative to the site and asecond, third or more treatment dosage can be administered. The factthat the dosage is at a low energy the common problem of localizedhemorrhaging is reduced making it more practical to administer multipledosages of waves from various orientations to further optimize thetreatment and cellular stimulation of the target site. Heretoforefocused high energy multiple treatments induced pain and discomfort tothe patient. The use of low energy focused or un-focused waves at thetarget site enables multiple sequential treatments. Alternatively, thewave source generators may be deployed in an array wherein the subjectpatient is effectively enveloped or surrounded by a plurality of lowenergy wave source generators which can be simultaneously bombarding thetarget site from multiple directions.

The goal in such treatments is to provide 100 to 3000 acoustic shockwaves or pressure pulses at a voltage of 14 kV to 28 kV across a sparkgap generator in a single treatment preferably or one or more adjuvanttreatments by targeting the site impinging the emitted waves on thedesired reflexology target.

The present method, in many cases, does not rely on precise sitelocation per se. The physician's general understanding of the anatomy ofthe patient should be sufficient to locate the reflexology target siteto be treated. The treated area can withstand a far greater number ofshock waves based on the selected energy level being emitted. Forexample, at very low energy levels the stimulation exposure can beprovided over prolonged periods as much as 20 minutes if so desired. Athigher energy levels the treatment duration can be shortened to lessthan a minute, less than a second if so desired. The limiting factor inthe selected treatment dosage is avoidance or minimization of cellhemorrhaging and other kinds of damage to the cells or tissue whilestill providing a stimulating cellular release or activation of VEGF andother growth factors and most importantly to modulate and regulatehormonal secretions from a specific targeted gland by emitting waves toa desired reflexology zone. In other cases where the precise locationmust be known, the use of an applicator acoustic wave emission isdirected by an ultrasound image, preferably the applicator has asoftware program coupled to the imaging device to allow the doctor tovisualize the area being treated. The applicator can be hand held ormanipulated in a fixture, if so desired, in either way the doctor cansee the reflexology zone for any gland to be stimulated and the selectedreflexology zone reflects the path of the wave transmission to modulatethat bone structure, nerve or gland.

A key advantage of the present inventive methodology is that it iscomplimentary to conventional medical procedures. In the case of anyother procedure, the area of the patient can be post operativelybombarded with these low energy waves to stimulate cellular release ofhealing agents and growth factors. Most preferably such patients may beprovided more than one such ESWT treatment with an intervening dwelltime for cellular relaxation prior to secondary and tertiary treatments.

The underlying principle of these shock wave therapy methods is tostimulate the body's own natural healing capability through thereflexology zone. This is accomplished by deploying shock waves tostimulate strong cells in the tissue to activate a variety of responses.The acoustic shock waves or pressure pulses transmit or trigger whatappears to be a cellular communication throughout the entire anatomicalstructure, this activates a generalized cellular response at thetreatment site, in particular, but more interestingly a systemicresponse in areas more removed from the wave form pattern. This isbelieved to be one of the reasons molecular stimulation can be conductedat threshold energies heretofore believed to be well below thosecommonly accepted as required. Accordingly, not only can the energyintensity be reduced but also the number of applied shock wave impulsescan be lowered from several thousand to as few as one or more pulses andstill yield a beneficial stimulating response. This allows acoustic wavetherapies to be directed to a specific reflexology zone directed toward,for example, an endocrine gland being treated with confidence the signalwill be fed back to the entire system via the pituitary gland(hypophysis). This use of acoustic wave stimulation allows a therapy tobe given to modulate and adjust glandular secretions of hormones to beregulated and adjusted to achieve a desired adjustment, for example iftoo low to increase specific secretions, if too high to lessen thesesecretions. Most importantly, the modulation of and reduction of paincan be achieved in the bone structure and nerves affected by a medicalcondition and/or medical procedure.

The biological model motivated the design of sources with low pressureamplitudes and energy densities. First: spherical waves generatedbetween two tips of an electrode; and second: nearly even wavesgenerated by generated by generalized parabolic reflectors. Third:divergent shock front characteristics are generated by an ellipsoidbehind F2. Unfocused sources are preferably designed for extended twodimensional areas/volumes like skin. The unfocused sources can provide adivergent wave pattern or a nearly planar wave pattern and can be usedin isolation or in combination with focused wave patterns yielding to animproved therapeutic treatment capability that is non-invasive with fewif any disadvantageous contraindications. Alternatively, a focused waveemitting treatment may be used wherein the focal point extends to thedesired reflexology zone or site, preferably at or beyond the targetreflexology treatment site within or even potentially external to thepatient. In any event, the beam of acoustic waves transmitted needs toproject in a large enough reflexology zone or area to stimulate ormodulate the gland. This results in the reduction of or elimination of alocalized intensity zone with associated noticeable pain effect whileproviding a wide or enlarged treatment volume at a variety of depthsmore closely associated with high energy focused wave treatment. Theutilization of a diffuser type lens or a shifted far-sighted focal pointfor the ellipsoidal reflector enables the spreading of the wave energyto effectively create a convergent but off target focal point. Thisinsures less tissue trauma while insuring cellular stimulation toenhance the healing process.

This method of treatment has the steps of, locating a reflexologytreatment site or zone, generating either focused shock waves orunfocused shock waves, of directing these shock waves to the treatmentsite; and applying a sufficient number of these shock waves to induceactivation of one or more growth factor thereby inducing or acceleratinga modulated adjustment to achieve a proper regulated glandular,muscular, bone or nerve response.

The unfocused shock waves can be of a divergent wave pattern or nearplanar pattern preferably of a low peak pressure amplitude and density.Typically, the energy density values range as low as 0.000001 mJ/mm² andhaving a high end energy density of below 1.0 mJ/mm², preferably 0.40mJ/mm² or less, more preferably 0.20 mJ/mm² or less. The peak pressureamplitude of the positive part of the cycle should be above 1.0 and itsduration is below 1-3 microseconds.

The treatment depth can vary from the surface to the full depth of thehuman or animal torso and the treatment site can be defined by a muchlarger treatment area than the 0.10-3.0 cm² commonly produced by focusedwaves. The above methodology is particularly well suited for surface aswell as sub-surface soft tissue treatments in one or more reflexologyzones or to one or more reflexology zones and to an area near the sourceof the pain.

An exemplary treatment protocol could have emitted shock waves in abroad range of 0.01 mJ/mm² to 3.0 mJ/mm² and 200-2500 pulses pertreatment with a treatment schedule of 1-3 weekly treatments untilsymptoms reduce. This can be repeated as symptoms reoccur or continueweekly as a preventative. The post medical treatment is beneficial as apain suppressor and reduces the need for pain medications and allowsless addictive medications to be used to prevent addiction. In othertreatment protocols, the emitted shock waves or pressure pulses canemploy as few as 1 to as high as 100,000 pulses per treatment.

The above methodology is valuable in generation of tissue,vascularization and may be used in combination with stem cell therapiesas well as regeneration of tissue and vascularization.

The following invention description first provides a detailedexplanation of acoustic shock waves or pressure pulses, as illustratedin FIGS. 1-9. As used herein an acoustic shock wave is an asymmetricwave with an exceptionally rapid peak rise time and slower return timefrom the peak amplitude. Historically, these acoustic shock waves orpressure pulses were first used medically to destroy kidney stones. Thewave patterns were directed to a focal point with ah a relatively highenergy to blast the concrements into small urinary tract passablefragments.

A whole class of acoustic shock waves or pressure pulses for medicaltreatments were later discovered that employed low energy acoustic shockwaves or pressure pulses. These low energy acoustic shock waves orpressure pulses maintained the asymmetric wave profile, but at muchlower energies as described in US2006/0100550 which is incorporatedherein in its entirety.

These low energy acoustic shock waves or pressure pulses advantageouslycould stimulate a substance without requiring a focused beam. Theadvantage of such an unfocused beam was the acoustic wave could bedirected to pass through tissue without causing any cell rupturing whichwould be evidenced by a lack of a hematoma or bruising. This use ofunfocused, low energy acoustic shock waves or pressure pulses providedan ability to treat a large volume of tissue virtually painlessly.Furthermore, the acoustic energy caused a short duration anestheticsensation that effectively numbs the patient's pain over a period ofdays with a prolonged reduction in pain thereafter.

The use of low energy acoustic shock waves or pressure pulses thatemploy a focused beam has been spurred on as a viable alternative to theunfocused low energy shock waves because the focal point being of asmall point of energy has little or a small region of cell damage as theremaining portions of the wave pattern can provide a stimulating effectsimilar to the unfocused shock waves. Basically, the effect is the samewith the users of focused waves achieving the benefits of the unfocusedwaves, but with a focal point of peak energy in a tiny localised region.So, for purposes of the present invention, the use of “soft waves” thosedefined by low energy beams will be applicable to both focused andunfocused beams o acoustic shock waves or pressure pulses for thepresent invention.

One last and significant point that the reader must appreciate is thatan “acoustic shock wave” is not an “ultrasound wave”. Sonic orultrasound waves are generated with a uniform and symmetrical wavepattern similar to a sinusoidal wave. This type of sonic wave causes asheer action on tissue as evidenced by a generation of heat within thetissue, for this reason, the use of sonic waves of the ultrasonic typeare not considered as efficient in cell survivability rates.

The present preferred invention avoids the use of such cell damagingsonic waves, most particularly in treating glands, bone structures ornerves via a targeted reflexology zone.

With reference to FIGS. 1-9, a variety of schematic views of acousticshock waves or pressure pulses are described. The following descriptionof the proper amplitude and pressure pulse intensities of the shockwaves 200 are provided below along with a description of how the shockwaves actually function and have been taken from the co-pendingapplication of the present inventors and replicated herein as describedbelow. For the purpose of describing the shock waves 200 were used asexemplary and are intended to include all of the wave patterns discussedin the figures as possible treatment patterns.

FIG. 1 is a simplified depiction of a pressure pulse/shock wave (PP/SW)generator, such as a shock wave head, showing focusing characteristicsof transmitted acoustic pressure pulses. Numeral 1 indicates theposition of a generalized pressure pulse generator, which generates thepressure pulse and, via a focusing element, focuses it outside thehousing to treat diseases. The affected tissue or organ is generallylocated in or near the focal point which is located in or near position6. At position 17, a water cushion or any other kind of exit window forthe acoustical energy is located.

FIG. 2 is a simplified depiction of a pressure pulse/shock wave orpressure pulse generator, such as a shock wave head, with plane wavecharacteristics. Numeral 1 indicates the position of a pressure pulsegenerator according to the present invention, which generates a pressurepulse which is leaving the housing at the position 17, which may be awater cushion or any other kind of exit window. Somewhat even (alsoreferred to herein as “disturbed”) wave characteristics can begenerated, in case a paraboloid is used as a reflecting element, with apoint source (e.g. electrode) that is located in the focal point of theparaboloid. The waves will be transmitted into the patient's body via acoupling media such as, e.g., ultrasound gel or oil and their amplitudeswill be attenuated with increasing distance from the exit window 17.

FIG. 3 is a simplified depiction of a pressure pulse shock wave orpressure pulse generator (shock wave head) with divergent wavecharacteristics. The divergent wave fronts may be leaving the exitwindow 17 at point 11 where the amplitude of the wave front is veryhigh. This point 17 could be regarded as the source point for thepressure pulses. In Fig le the pressure pulse source may be a pointsource, that is, the pressure pulse may be generated by an electricaldischarge of an electrode under water between electrode tips. However,the pressure pulse may also be generated, for example, by an explosion,referred to as a ballistic pressure pulse. The divergent characteristicsof the wave front may be a consequence of the mechanical setup.

This apparatus, in certain embodiments, may be adjusted/modified/or thecomplete shock wave head or part of it may be exchanged so that thedesired and/or optimal acoustic profile such as one having wave frontswith focused, planar, nearly plane, convergent or divergentcharacteristics can be chosen.

A change of the wave front characteristics may, for example, be achievedby changing the distance of the exit acoustic window relative to thereflector, by changing the reflector geometry, by introducing certainlenses or by removing elements such as lenses that modify the wavesproduced by a pressure pulse/shock wave generating element. Exemplarypressure pulse/shock wave sources that can, for example, be exchangedfor each other to allow an apparatus to generate waves having differentwave front characteristics are described in detail below.

In one embodiment, mechanical elements that are exchanged to achieve achange in wave front characteristics include the primary pressure pulsegenerating element, the focusing element, the reflecting element, thehousing and the membrane. In another embodiment, the mechanical elementsfurther include a closed fluid volume within the housing in which thepressure pulse is formed and transmitted through the exit window.

In one embodiment, the apparatus of the present invention is used incombination therapy. Here, the characteristics of waves emitted by theapparatus are switched from, for example, focused to divergent or fromdivergent with lower energy density to divergent with higher energydensity. Thus, effects of a pressure pulse treatment can be optimized byusing waves having different characteristics and/or energy densities,respectively.

While the above described universal toolbox of the various types ofacoustic shock waves or pressure pulses and types of shock wavegenerating heads provides versatility, the person skilled in the artwill appreciate that apparatuses that produce low energy or softacoustic shock waves or pressure pulses having, for one example, nearlyplane characteristics, are less mechanically demanding and fulfill therequirements of many users.

As the person skilled in the art will also appreciate that embodimentsshown in the drawings are independent of the generation principle andthus are valid for not only electro-hydraulic shock wave generation butalso for, but not limited to, PP/SW generation based on electromagnetic,piezoceramic and ballistic principles. The pressure pulse generatorsmay, in certain embodiments, be equipped with a water cushion thathouses water which defines the path of pressure pulse waves that is,through which those waves are transmitted. In a preferred embodiment, apatient is coupled via ultrasound gel or oil to the acoustic exit window(17), which can, for example, be an acoustic transparent membrane, awater cushion, a plastic plate or a metal plate.

FIG. 4a is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) having as focusing element anellipsoid (30). Thus, the generated waves are focused at (6).

FIG. 4b is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) having as a focusing elementan paraboloid (y2=2px). Thus, the characteristics of the wave frontsgenerated behind the exit window (33, 34, 35, and 36) are disturbedplane (“parallel”), the disturbance resulting from phenomena rangingfrom electrode burn down, spark ignition spatial variation todiffraction effects. However, other phenomena might contribute to thedisturbance.

FIG. 4c is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) having as a focusing elementa generalized paraboloid (yn=2px, with 1.2<n<2.8 and n i−2). Thus, thecharacteristics of the wave fronts generated behind the exit window (37,38, 39, and 40) are, compared to the wave fronts generated by aparaboloid (y2=2px), less disturbed, that is, nearly plane (or nearlyparallel or nearly even (37, 38, 39, 40)). Thus, conformationaladjustments of a regular paraboloid (y2=2px) to produce a generalizedparaboloid can compensate for disturbances from, e.g., electrode burndown. Thus, in a generalized paraboloid, the characteristics of the wavefront may be nearly plane due to its ability to compensate for phenomenaincluding, but not limited to, burn down of the tips of the electrodeand/or for disturbances caused by diffraction at the aperture of theparaboloid. For example, in a regular paraboloid (y2=2px) with p=1.25,introduction of a new electrode may result in p being about 1.05. If anelectrode is used that adjusts itself to maintain the distance betweenthe electrode tips (“adjustable electrode”) and assuming that theelectrodes burn down is 4 mm (z=4 mm), p will increase to about 1.45. Tocompensate for this burn down, and here the change of p, and to generatenearly plane wave fronts over the life span of an electrode, ageneralized paraboloid having, for example n=1.66 or n=2.5 may be used.An adjustable electrode is, for example, disclosed in U.S. Pat. No.6,217,531.

FIG. 4d shows sectional views of a number of paraboloids. Numeral 62indicates a paraboloid of the shape y2=2px with p=0.9 as indicated bynumeral 64 at the x axis which specifies the p/2 value (focal point ofthe paraboloid). Two electrode tips of a new electrode 66 (inner tip)and 67 (outer tip) are also shown in the Figure. If the electrodes arefired and the tips are burning down the position of the tips change, forexample, to position 68 and 69 when using an electrode which adjusts itsposition to compensate for the tip burn down. In order to generatepressure pulse/shock waves having nearly plane characteristics, theparaboloid has to be corrected in its p value. The p value for theburned down electrode is indicated by 65 as p/2=1. This value, whichconstitutes a slight exaggeration, was chosen to allow for an easierinterpretation of the Figure. The corresponding paraboloid has the shapeindicated by 61, which is wider than paraboloid 62 because the value ofp is increased. An average paraboloid is indicated by numeral 60 inwhich p=1.25 cm. A generalized paraboloid is indicated by dashed line 63and constitutes a paraboloid having a shape between paraboloids 61 and62. This particular generalized paraboloid was generated by choosing avalue of n cf. 2 and a p value of about 1.55 cm. The generalizedparaboloid compensates for different p values that result from theelectrode burn down and/or adjustment of the electrode tips.

FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shockwave or pressure pulse generator (43) (shock wave head) and a controland power supply unit (41) for the shock wave head (43) connected viaelectrical cables (42) which may also include water hoses that can beused in the context of the present invention. However, as the personskilled in the art will appreciate, other set-ups are possible andwithin the scope of the present invention.

FIG. 6 is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) having an electromagneticflat coil 50 as the generating element. Because of the plane surface ofthe accelerated metal membrane of this pressure pulse/shock wavegenerating element, it emits nearly plane waves which are indicated bylines 51. In shock wave heads, an acoustic lens 52 is generally used tofocus these waves. The shape of the lens might vary according to thesound velocity of the material it is made of. At the exit window 17 thefocused waves emanate from the housing and converge towards focal point6.

FIG. 7 is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) having an electromagneticflat coil 50 as the generating element. Because of the plane surface ofthe accelerated metal membrane of this generating element, it emitsnearly plane waves which are indicated by lines 51. No focusing lens orreflecting lens is used to modify the characteristics of the wave frontsof these waves, thus nearly plane waves having nearly planecharacteristics are leaving the housing at exit window 17.

FIG. 8 is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) having an piezoceramic flatsurface with piezo crystals 55 as the generating element. Because of theplane surface of this generating element, it emits nearly plane waveswhich are indicated by lines 51. No focusing lens or reflecting lens isused to modify the characteristics of the wave fronts of these waves,thus nearly plane waves are leaving the housing at exit window 17.Emitting surfaces having other shapes might be used, in particularcurved emitting surfaces such as those shown in FIGS. 4a to 4c as wellas spherical surfaces. To generate waves having nearly plane ordivergent characteristics, additional reflecting elements or lensesmight be used. The crystals might, alternatively, be stimulated via anelectronic control circuit at different times, so that waves havingplane or divergent wave characteristics can be formed even withoutadditional reflecting elements or lenses.

FIG. 9 is a simplified depiction of the pressure pulse/shock wave orpressure pulse generator (shock wave head) comprising a cylindricalelectromagnet as a generating element 53 and a first reflector having atriangular shape to generate nearly plane waves 54 and 51. Other shapesof the reflector or additional lenses might be used to generatedivergent waves as well.

FIG. 10 shows an exemplary shock wave device generator or source 1 witha control and power supply 41 connected to a hand-held applicator shockwave head 43 via a flexible hose 42 with fluid conduits. The illustratedshock wave applicator 43 has a flexible membrane at an end of theapplicator 43 which transmits the acoustic waves when coupled to theskin by using a fluid or acoustic gel. As shown, this type of applicator43 has a hydraulic spark generator using either focused or unfocusedshock waves, preferably in a low energy level, less than the range of0.01 mJ/mm² to 0.3 mJ/mm² The flexible hose 42 is connected to a fluidsupply that fills the applicator 43 and expands the flexible membranewhen filled. Alternatively, a ballistic, piezoelectric or sphericalacoustic shock wave device can be used to generate the desired waves.

FIG. 11 is a perspective view of a foot of a patient whose reflexologyzone or target 100 is being treated. A shock wave applicator head 43 isbrought into contact with the skin Ps preferably an acoustic gel is usedto enhance the transmission of the shock waves 200 through the skin Ps.The shock wave applicator head 43 can be hand held and manipulatedacross the skin Ps to drive the shock waves 200 in the direction theshock wave head 43 is pointed to activate a stimulating response throughthe reflexology zone 100. As illustrated, the device shown is anelectrohydraulic acoustic shock wave or pressure pulse generator,however, other devices that generate acoustic shock waves or pressurepulses can be used. Ultrasonic devices may be considered, but there isno data to support a sinusoidal wave form would work and therefore notconsidered as effective as the asymmetric wave generators. The acousticshock waves or pressure pulses activate a cellular response within thereflexology treatment site. This response or stimulation causes anincrease of nitric oxide and a release of a variety of growth factorssuch as VEGF. As shown, the flexible membrane is protruding outward andthe applicator 43 has been filled with fluid, the transmission oremission of acoustic shock waves or pressure pulses 200 is directedtowards the reflexology zone 100. In order to accomplish a goodtransmission, it is important the flexible membrane be pressed againstthe patient's skin Ps and as indicated coupling gels may be used. Thezone 100, as illustrated, is the reflexology zone for a bone structurewhich is a region of the foot located along an outside arch of eachfoot. By transmitting the shock waves 200 to the zone 100, is itbelieved that a modulation of the pain near the bone structure can bemade. This modulation or adjustment is achieved by transmitting theacoustic waves 200 at low energy directly onto the zone 100. It isbelieved that a single treatment of the zone 100 will achieve thedesired modulation. However, repeated treatments may be administered tohelp maintain and control this reduced pain level. Having achieved ascheduled pattern of treatments, it is possible to achieve regulation ofpain without the use of drugs or other stimulants.

With reference to FIG. 12, a view of a hand of a patient whosereflexology zone 100 is being treated with acoustic shock waves orpressure pulses 200 is illustrated. In this illustration, it isimportant to note that the applicator 43 presses against the skin Ps ofthe hand in the reflexology zone 100 for the pancreas which is a regionof the right hand in the fatty part below the index finger and a regionof the left hand below the middle finger close to the wrist.

With reference to FIGS. 13-13C, reflexology foot and ankle area chartsare shown detailing the various zones that correspond to organs, nerves,bones or glands of the body.

With reference to FIG. 14, a reflexology hand chart is shown detailingthe various zones that correspond to organs, nerves, bones or glands ofthe body.

The transmission of the shock waves 200 is preferred of a low energydensity of 0.2 mJ/mm² whether using focused or unfocused shock waves.The acoustic shock waves or pressure pulses pulse rapidly through thecells penetrating the cell membrane extremely rapidly due to the rapidrise to peak time and pass through exiting slower due to the slowerreturn from peak amplitude. This asymmetric wave pattern rapidlycompresses each cell on entry and slow decompresses the cell as itexits. This effective squeezing of each cell is believed to cause therelease of growth factors such as VEGF and others and also createsnitric oxide, all beneficial to new blood vessel formation. This occursas a transmission across the cell membranes without rupturing the nativecells.

Furthermore, such acoustic shock wave forms can be used in combinationwith drugs, chemical treatments, irradiation therapy or even physicaltherapy and when so combined the stimulated cells will more rapidlyassist the body's natural healing response and thus overcomes theotherwise potentially tissue damaging effects of these complimentaryprocedures.

The present invention provides an apparatus for an effective treatmentof indications, which benefit from high or low energy pressurepulse/shock waves having focused or unfocused, nearly plane, convergentor even divergent characteristics. With an unfocused wave having nearlyplane, plane, convergent wave characteristic or even divergent wavecharacteristics, the energy density of the wave may be or may beadjusted to be so low that side effects including pain are very minor oreven do not exist at all.

In certain embodiments, the apparatus of the present invention is ableto produce waves having energy density values that are below 0.1 mJ/mm²or even as low as 0.00 001 mJ/mm² In a preferred embodiment, those lowend values range between 0.1-0.01 mJ/mm² With these low energydensities, side effects are reduced and the dose application is muchmore uniform. Additionally, the possibility of harming surface tissue isreduced when using an apparatus of the present invention that generatesunfocused waves having planar, nearly plane, convergent or divergentcharacteristics and larger transmission areas compared to apparatusesusing a focused shock wave source that need to be moved around to coverthe affected area. The apparatus of the present invention also may allowthe user to make more precise energy density adjustments than anapparatus generating only focused shock waves, which is generallylimited in terms of lowering the energy output. Nevertheless, in somecases the first use of a high energy focused shock wave targeting atreatment zone may be the best approach followed by a transmission oflower energy unfocused wave patterns.

In the use of reflexology zones as the pathway or gate to control painresponse, the present invention has actual empirical data showing theeffectiveness in the zone directed to a bone. It is therefore furtherbelieved that similar modulation and beneficial adjustment can beachieved at other reflexology zones for stimulating, modulating oradjusting other glands, bones, nerves or organs such as the liver,kidney or any of those indicated in FIG. 13 for the foot zones and FIG.14 for the hand zones. It is further believed that the hybrid Easternmedical acupuncture treatments or massages historically used are farless effective and less reliable than the results achieved by the deepertissue penetrating transmission that are achieved by acoustic shock wavetherapy applied to these reflexology zones. Historically, the inventorinitially targeted treatment locations at the organ as in the patentU.S. Pat. No. 7,988,648 B2, but the present invention has found the useof the reflexology zones has achieved unexpected far superior results.

In the opioid or drug addition of the present invention, the inventorshave been able to prevent opioid addiction by treating a surgical siteimmediately before surgery, or immediately after (up to 24 hours after)surgery. Additionally, in conjunction with above, or independently ifthe surgical wound is treated at the first and second office visitpost-surgery addictive pain meds can be avoided. These surgical andpost-surgical treatments can greatly reduce the opioid addictionscreated surgically every year, estimated to be at over 2 millionAdditionally, serious traumas, those not requiring surgery, if treatedas soon as possible after the trauma, and continually on a daily orweekly basis until pain has subsided, will not require substantial painmedication. Shock wave or pressure pulse treatment replaces serious painmeds and or opioids. Additionally, the treatment helps a patient avoidor minimize withdrawal symptoms by treating their acute or chronic pain,and or by treating all of their reflexology zones on a weekly basisuntil symptoms subside. This is partly due to modulating hormonereleases from the glands including the adrenal gland. The adrenals canalso be targeted directly to enhance the effect to modulate withdrawalsymptoms.

There are two main groups of adrenoreceptors, α and β, with 9 subtypesin total: α are divided to α1 (a Gq coupled receptor) and α2 (a Gicoupled receptor); α1 has 3 subtypes: α1A, α1B and α1D; α2 has 3subtypes: α2A, α2B and α2C; β are divided to β1, β2 and β3. All 3 arecoupled to Gs proteins, but β2 and β3 also couple to Gi. Gi and Gs arelinked to adenylyl cyclase. Agonist binding thus causes a rise in theintracellular concentration of the second messenger cAMP. Gi inhibitsthe production of cAMP. Downstream effectors of cAMP includecAMP-dependent protein kinase (PKA), which mediates some of theintracellular events following hormone binding. Epinephrine (adrenaline)reacts with both α- and β-adrenoreceptors, causing vasoconstriction andvasodilation, respectively. Although a receptors are less sensitive toepinephrine, when activated at pharmacologic doses, they override thevasodilation mediated by β-adrenoreceptors because there are moreperipheral α1 receptors than β-adrenoreceptors. The result is that highlevels of circulating epinephrine cause vasoconstriction. However, theopposite is true in the coronary arteries, where β2 response is greaterthan that of α, resulting in overall dilation with increased sympatheticstimulation. At lower levels of circulating epinephrine (physiologicepinephrine secretion), β-adrenoreceptor stimulation dominates sinceepinephrine has a higher affinity for the β2 adrenoreceptor than the α1adrenoreceptor, producing vasodilation followed by decrease ofperipheral vascular resistance. Smooth muscle behavior is variabledepending on anatomical location. One important note is the differentialeffects of increased cAMP in smooth muscle compared to cardiac muscle.Increased cAMP will promote relaxation in smooth muscle, while promotingincreased contractility and pulse rate in cardiac muscle.

α receptors have actions in common, but also individual effects. Commonor still receptor unspecified actions include: vasoconstriction anddecreased motility of smooth muscle in gastrointestinal tract. Subtypeunspecific α agonists can be used to treat rhinitis, they decrease mucussecretion. Subtype unspecific a antagonists can be used to treatpheochromocytoma, they decrease vasoconstriction caused bynorepinephrine.

al-adrenoreceptors are members of the Gq protein-coupled receptorsuperfamily. Upon activation, a heterotrimeric G protein, Gq, activatesphospholipase C (PLC). The PLC cleaves phosphatidylinositol4,5-bisphosphate (PIP2), which in turn causes an increase in inositoltriphosphate (IP3) and diacylglycerol (DAG). The former interacts withcalcium channels of endoplasmic and sarcoplasmic reticulum, thuschanging the calcium content in a cell. This triggers all other effects,including a prominent slow after depolarizing current (sADP) in neurons.Actions of the al receptor mainly involve smooth muscle contraction. Itcauses vasoconstriction in many blood vessels, including those of theskin, gastrointestinal system, kidney, renal artery, and brain. Otherareas of smooth muscle contraction are: ureter, vas deferens, hair(arrector pili muscles), uterus (when pregnant), urethral sphincter,urothelium and lamina propria, bronchioles (although minor relative tothe relaxing effect of β2 receptor on bronchioles), blood vessels ofciliary body (stimulation causes mydriasis). Actions also includeglycogenolysis and gluconeogenesis from adipose tissue and liver;secretion from sweat glands and Na+ reabsorption from kidney. α1antagonists can be used to treat: hypertension, they decrease bloodpressure by decreasing peripheral vasoconstriction and benign prostatehyperplasia, they relax smooth muscles within the prostate thus easingurination.

The α2 receptor couples to the Gi/o protein. It is a presynapticreceptor, causing negative feedback on, for example, norepinephrine(NE). When NE is released into the synapse, it feeds back on the α2receptor, causing less NE release from the presynaptic neuron. Thisdecreases the effect of NE. There are also α2 receptors on the nerveterminal membrane of the post-synaptic adrenergic neuron. Actions of theα2 receptor include: decreased insulin release from the pancreas,increased glucagon release from the pancreas, contraction of sphinctersof the GI-tract, negative feedback in the neuronal synapses-presynapticinhibition of norepinephrine release in CNS, increased plateletaggregation (increased blood clotting tendency), decreases peripheralvascular resistance. α2 agonists can be used to treat: hypertension,they decrease blood pressure raising actions of the sympathetic nervoussystem, impotence, they relax penile smooth muscles and ease blood flowand depression, they enhance mood by increasing norepinephrinesecretion.

Subtype unspecific β agonists can be used to treat: heart failure, theyincrease cardiac output acutely in an emergency, circulatory shock, theyincrease cardiac output thus redistributing blood volume, andanaphylaxis-bronchodilation. Subtype unspecific β0 antagonists, betablockers, can be used to treat: heart arrhythmia, they decrease theoutput of sinus node thus stabilizing heart function, coronary arterydisease, they reduce heart rate and hence increasing oxygen supply,heart failure, they prevent sudden death related to this condition,which is often caused by ischemias or arrhythmias, hyperthyroidism, theyreduce peripheral sympathetic hyperresponsiveness, migraine, they reducenumber of attacks, stage fright, they reduce tachycardia and tremor,glaucoma, they reduce intraocular pressure.

Actions of the β1 receptor include: increase cardiac output byincreasing heart rate (positive chronotropic effect), conductionvelocity (positive dromotropic effect), stroke volume (by enhancingcontractility-positive inotropic effect), and rate of relaxation of themyocardium, by increasing calcium ion sequestration rate (positivelusitropic effect), which aids in increasing heart rate; increase reninsecretion from juxtaglomerular cells of the kidney and increase ghrelinsecretion from the stomach.

β2 adrenoreceptor (PDB: 2rhl) stimulates cells to increase energyproduction and utilization. Actions of the β2 receptor include: smoothmuscle relaxation throughout many areas the body, e.g. in bronchi(bronchodilation, see salbutamol), GI tract (decreased motility), veins(vasodilation of blood vessels), especially those to skeletal muscle(although this vasodilator effect of norepinephrine is relatively minorand overwhelmed by α adrenoceptor-mediated vasoconstriction), lipolysisin adipose tissue, anabolism in skeletal muscle, relax non-pregnantuterus, relax detrusor urinae muscle of bladder wall, dilate arteries toskeletal muscle, glycogenolysis and gluconeogenesis, stimulates insulinsecretion, contract sphincters of GI tract, thickened secretions fromsalivary glands, inhibit histamine-release from mast cells, increaserenin secretion from kidney, and involved in brain-immune communication.β2 agonists can be used to treat: asthma and COPD, they reduce bronchialsmooth muscle contraction thus dilating the bronchus, hyperkalemia, theyincrease cellular potassium intake, and preterm birth, they reduceuterine smooth muscle contractions.

Actions of the β3 receptor include: increase of lipolysis in adiposetissue. β3 agonists could theoretically be used as weight-loss drugs,but are limited by the side effect of tremors.

Shock wave or pressure pulse treatment can modulate alpha 1 and 2, beta,and other adrenergic receptors by directly targeting the tissue AND bythe stimulation of the reflexology zones. For example, by targeting thehearts reflexology zones you can modulate alpha receptors in the heart.Shock wave or pressure pulse treatment can recruit, activate anddifferentiate stem cells by directly targeting the pathologic tissue orby targeting the pertinent reflexology zones or preferably by doing bothin combination. This is the same for modulating inflammation locally bythe direct targeting or modulating SYSTEMIC inflammation by treating anyor all of the reflexology zones.

It will be appreciated that the apparatuses and processes of the presentinvention can have a variety of embodiments, only a few of which aredisclosed herein. It will be apparent to the artisan that otherembodiments exist and do not depart from the spirit of the invention.Thus, the described embodiments are illustrative and should not beconstrued as restrictive.

Variations in the present invention are possible in light of thedescription of it provided herein. While certain representativeembodiments and details have been shown for the purpose of illustratingthe subject invention, it will be apparent to those skilled in this artthat various changes and modifications can be made therein withoutdeparting from the scope of the subject invention. It is, therefore, tobe understood that changes can be made in the particular embodimentsdescribed which will be within the full intended scope of the inventionas defined by the following appended claims.

What is claimed is:
 1. A method of treating surgical patient to preventopioid addiction comprises the step of: treating the patient withacoustic shock waves or pressure pulses prior to surgery, duringsurgery, and up to two weeks after surgery, or any combination thereofto reduce post-surgical pain such that pain meds can be avoided ordrastically reduced.
 2. The method of claim 1 wherein the entiresurgical area is treated until pain has been resolved or reduced topoint where medications are not required.
 3. The method of claim 1wherein the acoustic shock waves or pressure pulses are directed to oneor more reflexology zones of the hands or feet for the purpose ofreducing pain and accelerating healing.
 4. The method of claim 1 whereinthe administration of emitted shock waves is additionally directed to anarea of the reflexology zone directed to modulate a response to the painto suppress urges to take the addictive medication or opioids and tominimize withdrawal symptoms; and further comprises the step of:recruiting, activating and differentiating stem cells by directlytargeting the pathologic tissue or by targeting the reflexology zones ordoing both.